RecruitingNCT07245927

Post-registration Trial of the Non-immunogenic Staphylokinase in Massive Pulmonary Embolism

An Open, Prospective, Non-interventional, Multicentre, Controlled Study of Safety and Efficacy of the Thrombolysis With the Non-immunogenic Staphylokinase in Patients With Massive Pulmonary Embolism (FORPE Registry)

Sponsor

Supergene, LLC

Enrollment

20,000 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

Pulmonary Embolism Acute Massive

Summary

The aim of FORPE Registry is to study the safety and efficacy of the non-immunogenic staphylokinase in patients with massive pulmonary embolism in routine clinical practice.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Men and women aged 18 years and older.
Verified diagnosis of massive pulmonary embolism (using computer tomography)
Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
The time from the symptoms onset is no more than 14 days.
Thrombolysis with the non-immunogenic staphylokinase, 15 mg as a single intravenous bolus.

Exclusion Criteria19

Increased risk of bleeding:
extensive bleeding at present or within the previous 6 months;
intracranial (including subarachnoid) hemorrhage at present or in history;
hemorrhagic stroke within the last 6 months;
a history of diseases of the central nervous system (including neoplasms, aneurysms);
intracranial or spinal surgical interventions within the last 2 months;
major surgery or major trauma within the previous 4 weeks;
recent puncture of an incompressible blood vessel (eg, subclavian or jugular vein);
severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
confirmed gastric or duodenal ulcer within the last 3 months;
neoplasm with an increased risk of bleeding;
simultaneous administration of Dabigatran without prior administration of idarucizumab;
arterial aneurysms, developmental defects of arteries / veins;
acute pancreatitis;
bacterial endocarditis, pericarditis;
suspicion of aortic dissecting aneurysm;
any other conditions, in the opinion of the investigator, associated with a high risk of bleeding.
Lactation, pregnancy.
Known hypersensitivity to the non-immunogenic recombinant staphylokinase.